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The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are reusable lancing devices intended to be used with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests that require small amounts of blood. The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are intended for single person use only.

The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are used with a compatible single-use lancet to puncture the skin and release a small amount of blood. The products are distributed individually or packaged together with blood glucose monitoring systems to obtain capillary whole blood samples required for testing blood glucose levels.

The provided text is an FDA 510(k) premarket notification approval letter for a Multi-Lancet Device 2 and ReliOn Premier Lancing Device. It focuses on demonstrating substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System) through comparisons of intended use, technological characteristics, and non-clinical performance testing.

Crucially, this document focuses on a medical device (lancing device) and not an AI/ML-driven medical device. Therefore, a significant portion of the requested information, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "training set size," and "how ground truth for training set was established," are not applicable to the information provided.

The document primarily describes the physical device and its mechanical and safety performance, not the performance of an AI algorithm.

Here's a breakdown of the available information based on your request, noting where information is not applicable (N/A) due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document mentions "Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life." It also states, "Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use."

However, specific numerical acceptance criteria (e.g., maximum allowed force for puncture, minimum number of uses before failure) and the reported device performance against these criteria are not detailed in this public FDA letter. The letter only confirms that such testing was done and met the requirements.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Non-Clinical bench testing." This typically involves laboratory testing of the physical device rather than a "test set" of clinical data (like medical images). The sample size for these bench tests is not specified, nor is the "data provenance" as it's not a clinical data study. The applicant's address is ARKRAY Factory, Inc., 1480 Koji, Konan-cho, Koka-shi, Shiga 520-3306 Japan, suggesting the company is based in Japan, but this doesn't explicitly state the location of the bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical lancing device, not an AI/ML-driven diagnostic tool that requires ground truth established by experts interpreting data (e.g., radiologists interpreting images). The "ground truth" for this device relates to its mechanical performance and safety, verified through specified testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" of patient data that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device, and no MRMC study would be conducted. The "assistance" provided by this device is mechanical (blood sampling), not interpretative or cognitive.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance, as implied, is established by bench test standards and regulatory requirements (e.g., 21 CFR 878.4850 special controls) regarding mechanical robustness, cleaning/disinfection effectiveness, and general safety. It's not a "truth" derived from clinical data like pathology or expert consensus.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment method.

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